(29 days)
The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.
The provided document describes the CLUNGENE HCG Pregnancy Rapid Test, a qualitative in vitro diagnostic device for early detection of pregnancy. The acceptance criteria and study details are primarily focused on the analytical performance and comparison with a predicate device, as this is a 510(k) submission for a Class II device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for each performance characteristic in a pass/fail format. However, based on the presented data, the implicit acceptance criterion for most analytical tests is 100% agreement/expected result at the defined concentrations. For the sensitivity, the acceptance criterion is implied to be 25 mIU/mL, as this is the claimed analytical detection limit, and the results show 100% positivity at 25 mIU/mL and above. For the method comparison and lay person studies, 100% concordance with the reference method (predicate device or professional testing) suggests an implicit acceptance criterion of 100% agreement.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: 100% positive at 25 mIU/mL hCG and above, and 100% negative at 12.5 mIU/mL hCG and below. | Strip Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. |
| Cassette Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. | |
| Midstream Format: 100% positive for 25 mIU/mL, 50 mIU/mL, 100 mIU/mL, 200 mIU/mL; 100% negative for 0 mIU/mL, 12.5 mIU/mL. | |
| Hook Effect: No hook effect observed at high hCG concentrations. | Tested up to 2,000,000 mIU/mL hCG. All tested concentrations gave a positive result, demonstrating no hook effect from 62500 to 2,000,000 mIU/mL. |
| Specificity/Cross-reactivity: No interference from high concentrations of related hormones (LH, FSH, TSH, hCG ß-core fragment). | No interference observed at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH, and 2,000,000 pmol/L hCG ß-core fragment for both negative (10 mIU/mL) and positive (25 mIU/mL) urine samples. |
| Interfering Substances: No interference from common endogenous and exogenous substances (various drugs, metabolites, etc.). | No interferences observed from a long list of exogenous compounds (e.g., Acetaminophen, Caffeine, Ethanol, Aspirin, etc.) at specified concentrations for both negative (10 mIU/mL) and positive (25 mIU/mL) hCG urine samples. No interference from changes in pH (4-9) or specific gravity (1.000-1.035) for 10 mIU/mL and 25 mIU/mL hCG samples. |
| Method Comparison (Conformity Rate): 100% positive and negative conformity with the predicate device. | Strip Format: 100% positive conformity (63/63), 100% negative conformity (57/57). |
| Cassette Format: 100% positive conformity (63/63), 100% negative conformity (57/57). | |
| Midstream Format: 100% positive conformity (63/63), 100% negative conformity (57/57). | |
| Lay Person Study (Conformity Rate): 100% positive and negative conformity with professional results. | Strip Format: 100% positive conformity (43/43), 100% negative conformity (57/57). |
| Cassette Format: 100% positive conformity (53/53), 100% negative conformity (47/47). | |
| Midstream Format: 100% positive conformity (50/50), 100% negative conformity (50/50). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Analytical Performance (Precision/Reproducibility/Sensitivity, Hook Effect, Specificity, Interfering Substances): Urine samples were spiked with hCG standards and various interfering substances. The origin of the initial negative urine is not specified but is typically a controlled laboratory setting. The study design for these tests appears to be prospective laboratory testing.
- Precision/Reproducibility/Sensitivity: 90 replicates per hCG concentration (3 lots * 30 replicates each) were tested for each of the three formats. Negative urine was spiked with hCG standard (Traceable to the 5th WHO).
- Hook Effect: Negative urine samples were spiked with varying hCG concentrations.
- Specificity and Cross-reactivity: Negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones and hCG ß-core fragment.
- Interfering Substance: Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substances.
- Method Comparison Study:
- Sample Size: 120 urine samples from women presenting to test for pregnancy. Approximately half were suspected to be pregnant and in early stages (less than 5 weeks).
- Data Provenance: Not explicitly stated but implies prospective collection from "POC sites" (Point-of-Care). Country of origin is not mentioned.
- Lay Person Study:
- Sample Size: 300 women.
- Data Provenance: Not explicitly stated, but participants were recruited from "three sites" for self-testing. Implies prospective collection. Country of origin not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Analytical Performance: The ground truth for analytical performance (e.g., hCG concentrations) was established by spiking known concentrations of hCG standard traceable to the 5th WHO, and preparing samples with known concentrations of interfering substances. This implies a laboratory setting with qualified personnel to perform and verify the spiking, but "experts" in the sense of clinical interpretation are not involved here.
- Method Comparison Study: The ground truth was established by testing all samples with the predicate device AND by "three different health professionals for each format at the 3 POC sites for a total of 12 POC operators." The qualifications of these "health professionals" or "POC operators" are not specified beyond being "health professionals."
- Lay Person Study: The ground truth was established by "professional testing" of the urine samples provided by the lay persons. The qualifications of these "professionals" are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Analytical Performance: Not applicable for spiked samples with known concentrations. The results are quantitative (e.g., 30 positives out of 30, 0 negatives out of 30).
- Method Comparison Study: The study involved professional testing of each sample by "three different health professionals" and comparison to the predicate device. It's not explicitly stated if there was an adjudication process if these three professionals disagreed among themselves, or if the predicate device result was considered the definitive ground truth for comparison. The tables indicate a direct comparison between the candidate device and the predicate device.
- Lay Person Study: Each lay person's result was compared to "professional testing." It's not explicitly stated if there was an adjudication for professional testing if multiple professionals were involved or if it was a single professional's reading.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is a rapid diagnostic test (HCG Pregnancy Rapid Test), not an AI-powered image analysis tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The "multi-reader" aspect in the method comparison and lay person studies refers to different operators/professionals performing the assay, not interpreting complex images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is a lateral flow immunoassay that produces a visual result, interpreted by a human user (either a professional or a lay person). There is no "algorithm only" component to evaluate in isolation. Its performance is its standalone performance when correctly used and interpreted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Performance: Ground truth was based on known, spiked concentrations of hCG (traceable to WHO International Standard) and other substances in urine. This is a highly controlled laboratory ground truth.
- Method Comparison Study: Ground truth was established by comparison to a legally marketed predicate device and readings by "health professionals." The predicate device results served as the reference standard.
- Lay Person Study: Ground truth was established by "professional testing" of the urine samples from the lay persons.
8. The sample size for the training set
- This document describes performance characteristics for a rapid diagnostic test. There is no mention of a "training set" as this is not an AI/machine learning model that requires training. The studies conducted are for analytical validation and clinical performance evaluation.
9. How the ground truth for the training set was established
- As there is no training set mentioned or implied for this type of device, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 11, 2019
Hangzhou Clongene Biotech Co.,Ltd. % Joe Shia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, Maryland 20877
Re: K193132
Trade/Device Name: CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: LCX Dated: November 8, 2019 Received: November 12, 2019
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices | OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
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Indications for Use
510(k) Number (if known) K193132
Device Name
CLUNGENE HCG Pregnancy Rapid Test Cassette CLUNGENE HCG Pregnancy Rapid Test Strip CLUNGENE HCG Pregnancy Rapid Test Midstream
Indications for Use (Describe)
The CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
The CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K193132
510(k) SUMMARY
| 1. Date: | December 09, 2019 |
|---|---|
| 2. Submitter: | Hangzhou Clongene Biotech Co., Ltd.20 Longquan RoadHangzhou 311121, ChinaTelephone: 86-571-88262120Fax: 86-571-88261752 |
| 3. Contact person: | Joe ShiaLSI International Inc.504 East Diamond Ave., Suite JGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com |
| 4. Device Name: | CLUNGENE HCG Pregnancy Rapid Test CassetteCLUNGENE HCG Pregnancy Rapid Test MidstreamCLUNGENE HCG Pregnancy Rapid Test Strip |
| Classification: | Class II |
| Product Code | CFR # | Panel |
|---|---|---|
| LCX | 21 CFR, 862.1155 Human chorionic gonadotropin(hCG) Test System | ClinicalChemistry (75) |
-
- Predicate Devices: EGENS One Step HCG Urine Pregnancy Test (K123050)
6. Intended Use
CLUNGENE HCG Pregnancy Rapid Test Cassette is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
CLUNGENE HCG Pregnancy Rapid Test Midstream is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
CLUNGENE HCG Pregnancy Rapid Test Strip is a rapid one step assay designed for qualitative detection of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy.
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7. Device Description
Clungene HCG Pregnancy Rapid Test will be sold in three different formats: Cassette, Test Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and a package insert. The Cassette format contains one test device, a disposable plastic dropper, and a package insert.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device K123050 |
| Intended use | Early detection ofpregnancy | Early detection ofpregnancy |
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographicassay | Immunochromatographicassay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Device format | Strip, Cassette, Midstream | Strip, Cassette, Midstream |
| Differences | ||
| Item | Device | Predicate |
| Reading Time | 3 minute | 5 minute |
Substantial Equivalence Information 8.
Standard/Guidance Document Reference (if applicable) 9.
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, July 22, 2000
10. Test Principle
This device operates by detecting human chorionic gonadotropin (hCG), the hormone produced during pregnancy in urine, using a lateral flow sandwich immunochromatographic assay.
11. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility/Sensitivity
Negative urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 18.75, 22.5, 25, 50, 100 and 200mIU/mL. The spiked samples were measured in replicates using 3 different lots for each format. Tests were performed by three different operators for each sample concentration in 2 runs per day for 15 days. The results are summarized in the table below:
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Strip format
| hCGConcentration(mIU/mL) | Lot 1 | Lot 2 | Lot 3 | Total result | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 22 | 8 | 25 | 5 | 25 | 5 | 72 | 18 | 80 | 20 |
| 22.5 | 13 | 17 | 14 | 16 | 17 | 13 | 44 | 46 | 48.9 | 51.1 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Cassette format
| hCGConcentration(mIU/mL) | Lot 1 | Lot 2 | Lot 3 | Total result | %Negative | %Positive | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | |||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 |
| 18.75 | 25 | 5 | 24 | 6 | 24 | 6 | 73 | 17 | 81.1 | 18.9 |
| 22.5 | 15 | 15 | 13 | 17 | 13 | 17 | 41 | 49 | 45.6 | 54.4 |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Midstream format
| hCGConcentration(mIU/mL) | Lot 1 | Lot 2 | Lot 3 | Total result | %Negative | %Positive | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| - | + | - | + | - | + | - | + | ||||
| 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 12.5 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | 0 | |
| 18.75 | 23 | 7 | 23 | 7 | 25 | 5 | 71 | 19 | 78.9 | 21.1 | |
| 22.5 | 16 | 14 | 17 | 13 | 14 | 16 | 47 | 43 | 52.2 | 47.8 | |
| 25 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 50 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 100 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 | |
| 200 | 0 | 30 | 0 | 30 | 0 | 30 | 0 | 90 | 0 | 100 |
Based on the above results, the sensitivity of CLUNGENE HCG Pregnancy Rapid Test is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
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Linearity is not applicable since this is a qualitative test.
c. Hook effect test:
Negative urine samples were spiked with varying hCG concentrations (62500, 125000, 250000, 500000, 1000000 and 2000000 mIU/mL). All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentrations ranging from 62500 to 2000,000 mIU/mL.
d. Traceability, Stability, Expected values (controls, calibrators, or methods):
CLUNGENE HCG Pregnancy Rapid Test is calibrated against reference material traceable to WHO International Standard 5th edition.
A shelf-life stability test of the devices was performed by accelerated testing. The results showed that the devices were stable for 24 months when stored at 4~30℃ in the sealed foil pouch. Real time stability studies are ongoing.
e. Specificity and cross reactivity
To evaluate specificity and cross-reactivity, negative and positive urine samples (10 mIU/mL and 25 mIU/mL) were spiked with various concentrations of glycoprotein hormones LH, FSH, TSH and hCG ß-core fragment. The results showed that there is no interference at 500 mIU/mL LH, 1000 mIU/mL FSH, 1000 mIU/L TSH and 2000,000 pmol/L hCG ß-core fragment for both negative and positive urine samples.
f. Interfering substance
To evaluate the potential for interference by certain exogenous compounds, each interfering substance was prepared by diluting stock interfering material to the desired concentration. Urine samples containing 10 mIU/mL and 25 mIU/mL hCG were spiked with the interfering substance to obtain the desired test concentration. No interferences were observed from exogenous compounds at the following concentrations for both negative and positive hCG urine samples.
| Substances | Concentration |
|---|---|
| Acetaminophen | 20mg/dL |
| Acetoacetic Acid | 2000mg/dL |
| Asorbic Acid | 20mg/dL |
| B-hydroxybutyrate | 2000mg/dL |
| Caffeine | 20mg/dL |
| Ephedrine | 20mg/dL |
| Gentisic Acid | 20mg/dL |
| Phenylpropanolamine | 20mg/dL |
| Salicylic Acid | 20mg/dL |
| Phenothiazine | 20mg/dL |
| EDTA | 80mg/dL |
| Acetylsalicylic Acid | 20mg/dL |
| Benzoylecgonine | 10mg/dL |
| Cannabinol | 10mg/dL |
| Codeine | 6ug/dL |
| Ethanol | 1.0% |
| Methanol | 10% |
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| Albumin | 2000mg/dL |
|---|---|
| Glucose | 2000mg/dL |
| Bilirubin | 2mg/dL |
| Atropine | 20mg/dL |
| Estriol-17-beta | 1400ug/dL |
| Hemoglobin | 500mg/dL |
| Pregnanediol | 1500ug/dL |
| Thiophene | 20mg/dL |
| Ampicillin | 20mg/dL |
| Tetracycline | 20mg/dL |
| Ketone | 20mg/dL |
To evaluate potential interference from changes in pH, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that changes in pH range of 4~9 do not interfere in the results that were either positive or negative for hCG.
To evaluate potential interference from changes in specific gravity, urine samples containing 10 mIU/mL and 25 mIU/mL hCG were tested at density values ranging from 1.000 to 1.035. The results indicated that changes in specific gravity do not interfere in the results that were either positive or negative for hCG.
B. Method comparison study
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 120 women presenting to test for pregnancy. Approximately half of the 120 women were suspected to be pregnant and most of them are in the early stage of less than 5 weeks. All samples were tested by three different health professionals for each format at the 3 POC sites for a total of 12 POC operators with the proposed and the predicate devices.
| Strip Format | Predicate device | ||
|---|---|---|---|
| Positive | Negative | ||
| CLUNGENE HCG®Rapid Pregnancy Test | Positive | 63 | 0 |
| Negative | 0 | 57 |
| Predicate device | |||
|---|---|---|---|
| Cassette | Positive | Negative | |
| CLUNGENE HCG®Rapid Pregnancy Test | Positive | 63 | 0 |
| Negative | 0 | 57 |
| Midstream | Predicate device | |
|---|---|---|
| Positive | Negative |
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| CLUNGENE HCG®Rapid Pregnancy Test | Positive | 63 | 0 |
|---|---|---|---|
| Negative | 0 | 57 |
Conclusion from the above table:
The average positive conformity rate of Rapid Pregnancy Test is 100%. The average negative conformity rate of Rapid Pregnancy Test is 100%
C. Lay person study:
300 women's individual pregnancy status was self-tested, varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Summary
| Rapid Pregnancy Test Strip | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 43 | 0 |
| - | 0 | 57 |
| Rapid Pregnancy Test Cassette | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 53 | 0 |
| - | 0 | 47 |
| Rapid Pregnancy Test Midstream | Professional | ||
|---|---|---|---|
| + | - | ||
| Lay person | + | 50 | 0 |
| - | 0 | 50 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
12. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.